FDA.reportPublic FDA data

ITIRES

Manufacturer
PEKANA Naturheilmittel GmbH
Effective date
2022-12-16
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:19:01

Label at a glance#

ProductITIRES
Active ingredientBarium Carbonate, Calcium Iodide, Helianthemum canadense, Conium maculatum Flowering Top, SCROPHULARIA NODOSA WHOLE, Echinacea, unspecified, GALIUM APARINE WHOLE, Juglans regia Whole
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ingredients:
Barium carbonicum8X
Calcium jodatum8X
Helianthemum canadense (Cistus canadensis)12X
Conium maculatum6X
Echinacea angustifolia12X
Galium aparine6X
Juglans regia6X
Scrophularia nodosa4X

Selected ingredients prepared by spagyric processes.

INACTIVE INGREDIENT SECTION

Contains 18% alcohol by volume.

Indications

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Helps cleanse and detoxify the body. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.

Dosage

DOSAGE & ADMINISTRATION SECTION

Unless otherwise prescribed, adults take 15-20 drops, 3 times per day. For pediatric dosages, consult your practitioner.

Warning

WARNINGS SECTION

If symptoms persist, contact a licensed practitioner. If you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. If you are pregnant or nursing a baby, seek the advice of a health care professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

STORAGE AND HANDLING SECTION

Protect from light and heat.

Tamper Evident

SPL UNCLASSIFIED SECTION

Do not use this product if tamper evident strip is broken or removed from base of cap.

OTC - QUESTIONS SECTION

To report adverse events, contact BioResource at 321B Blodgett Street, Cotati, CA 94931

SPL UNCLASSIFIED SECTION

Distributed by:
BioResource Inc.
Cotati, CA 94931

Manufactured by:
PEKANA® GmbH
D-88353 Kisslegg

PRINCIPAL DISPLAY PANEL - 100 ml Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ITIRES™
Oral Drops

Homeopathic Medicine

Helps cleanse and
detoxify the body

3.34 FL OZ
(100 ml)

PEKANA®

PRINCIPAL DISPLAY PANEL - 100 ml Bottle Box
PRINCIPAL DISPLAY PANEL - 100 ml Bottle Box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-112-10ITIRES1 in 1 BOXSOLUTION/ DROPS15
59469-112-10ITIRES50 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS505
59469-112-30ITIRES100 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS1005
59469-112-30ITIRES1 in 1 BOXSOLUTION/ DROPS15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-112ITIRES (BARIUM CARBONATE, CALCIUM IODIDE, HELIANTHEMUM CANADENSE, CONIUM MACULATUM FLOWERING TOP, SCROPHULARIA NODOSA, ECHINACEA, UNSPECIFIED, GALIUM APARINE, AND JUGLANS REGIA WHOLE) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL GMBH]5Current NDC, Legacy NDC, 4 package rows20221221_5b680209-74e6-4470-810a-fe141f8bf40f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59469-11259469-112-10, 59469-112-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
Barium Carbonate6P669D8HQ8ACTIB
Calcium Iodide8EKI9QEE2HACTIB
Helianthemum canadense46G3W789Q3ACTIB
Conium maculatum Flowering TopQ28R5GF371ACTIB
SCROPHULARIA NODOSA WHOLE7H443NUB2TACTIB
Echinacea, unspecified4N9P6CC1DXACTIB
GALIUM APARINE WHOLEZ4B6561488ACTIB
Juglans regia Whole87EJ76IO83ACTIB
Water059QF0KO0RIACT
Alcohol3K9958V90MIACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ITIRESBARIUM CARBONATE, CALCIUM IODIDE, HELIANTHEMUM CANADENSE, CONIUM MACULATUM FLOWERING TOP, SCROPHULARIA NODOSA, ECHINACEA, UNSPECIFIED, GALIUM APARINE, AND JUGLANS REGIA WHOLEPEKANA Naturheilmittel GmbH5b680209-74e6-4470-810a-fe141f8bf40f2022-12-16WarningsExact identifier
ndc (package): 59469-112-30
ndc (package): 59469-112-10
ndc (product): 59469-112
ndc11 (package): 59469011230
ndc11 (package): 59469011210
spl id: 21cd4bc8-e0bb-40f2-bd88-1ea1be9430c3
spl set id: 5b680209-74e6-4470-810a-fe141f8bf40f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.